MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number	3146
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event and patient weight are estimated.A patient's ipg reached end of life was reported to abbott.As a result, the patient's ipg explanted and replaced.It was determined that during a ipg replacement procedure, one of the leads was visually confirmed to be fractured and another lead had migrated which was confirmed through x-ray imaging.As a result, surgical intervention was undertaken wherein the system was explanted and replaced to address the issue.
Event or Problem Description
It was reported that during a ipg replacement procedure on (b)(6) 2026, one of the quattrode leads was visually confirmed to be fractured and another quattrode lead had migrated which was confirmed through x-ray imaging.As a result, surgical intervention was undertaken wherein the system was explanted and replaced to address the issue.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 25331609
• Report Number: 1627487-2026-07806
• Device Sequence Number: 9861344
• Product Code: LGW
• UDI-Device Identifier: 05414734401586
• UDI-Public: (01)05414734401586(10)3761161(17)140728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 3146
• Device Catalogue Number: 3146
• Device Lot Number: 3761161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 70 KG